EUCTR2010-021445-42-BE进行中（未招募）1 期
A multicenter, randomized phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL amyloidosis
HOVON Foundation0 个研究点目标入组 50 人开始时间: 2011年10月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Biopsy proven, systemic, untreated AL amyloidosis requiring systemic chemotherapy,
- •Age 18 -70 years inclusive at the time of signing the informed consent form,
- •Measurable plasma cell dyscrasia, defined as a detectable M-protein with serum electrophoresis and/or level of involved FLC> 50 mg/L,
- •Life expectancy > 3 months,
- •WHO performance status 0-2,
- •NYHA 1-2,
- •Negative pregnancy test at inclusion for women of childbearing potential,
- •Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Multiple Myeloma stage II and III (Durie and Salmon),
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
- •Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule,
- •Previous treatment for plasma cell dyscrasia
- •Pregnant or breast feeding females.
- •Presence of other active malignancy or a history of active malignancy during the past 5 years, with the exception of nonmelanoma skin cancer, stage 0 cervical carcinoma, or treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits,
- •Hypersensitivity to boron or mannitol,
- •Uncontrolled infection,
- •Symptomatic othostatic hypotension defined as a decrease in systolic blood pressure on standing of >20mmHg combined with symptoms like dizziness, cerebral and/or cardial ischemia,
- •Symptomatic effusions, defined as pleural effusion or ascites needing drainage therapy,
- •NT pro BNP level > 5000 pg/ml and troponin T>0.06 microgram/L (not high sensitivity assay) or NT proBNP level>5000 pg/ml and Troponin I > 2 times ULN.
- •- Positive for HIV or infectious hepatitis, B or C,
- •Bilirubin > 2x upper limit of normal,
- •Creatinin clearance < 30 ml/min (after rehydration),
- •Absolute neutrophil count < 1.0 × 109/L,
- •NCI CTCAE grade peripheral sensory neuropathy > grade 2,
- •NCI CTCAE grade peripheral sensory neuropathy > grade 1 in the presence of neuropathic pain,
- •NCI CTCAE grade peripheral motor neuropathy > grade 2
- •Concurrent diagnosis of B-cel NHL or B-CLL,
- •Previous organ transplantation.
- •Unwilling or unable to use adeaquate contraception
研究者
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